Botulinum Toxin to Treat Restless Legs Syndrome

NCT00479154 | Completed Phase 1 Results

• 2 other identifiers: 07016007-N-0160
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test whether botulinum toxin (Botox) may relieve the uncomfortable sensations patients with restless legs syndrome (RLS) experience. RLS is a common movement disorder that causes sensory discomfort and restlessness, most often in the legs, which improves with movement. Although medications are available to treat the disorder, many people experience side effects that prevent them from continuing on the medication. The Food and Drug Administration has approved Botox for other movement disorders and for some cosmetic uses. People 18 years of age or older with moderate to severe RLS who have been taking RLS medications for more than 6 weeks before entering the study may be eligible to participate. Candidates are screened with a medical history, physical and neurological examinations, blood tests and, for women who can become pregnant, a urine pregnancy test. Participants are randomly assigned to receive injections of either Botox or placebo (salt water) into up to nine areas of the legs. The correct location of the muscles to be injected is determined by electromyography (EMG), a test that measures the electrical activity of muscles. For surface EMG, electrodes (small metal disks) are filled with a conductive gel and taped to the skin. Needle EMG involves inserting a needle into a muscle. Both methods are used in this study. At 2 and 4 weeks after the injections, subjects are interviewed by telephone and asked to describe their symptoms, side effects and any improvement they may have noticed. After 12 weeks they return to NIH for injections with the alternate compound; that is, those who received Botox previously are given placebo for the second set of injections, and vice-versa. Subjects are again contacted by telephone 2 and 4 weeks after the injections to report their symptoms, side effects and benefits.

Conditions

Restless Legs Syndrome

Keywords

Restless Leg Syndrome; Botulinum Toxin; RLS

Outcome Measures

Primary Outcomes (1)

• Change in Restless Legs Syndrome Rating Scale

  Primary outcome measure will be the mean change from baseline in RLS scale at week 2 following placebo/BTX injections. Scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40).

  Week 2 and Week 4 for each intervention (vs. baseline)

Study Arms (2)

Botulinum Toxin A

EXPERIMENTAL

Injection of onabotulinumtoxinA

Drug: Botulinum Toxin A

Placebo (saline)

PLACEBO COMPARATOR

Injection of saline placebo

Drug: Botulinum Toxin A

Interventions

Botulinum Toxin A DRUG

Maximum dose of 90 units/leg was injected.

Also known as: onabotulinum toxin

Botulinum Toxin A; Placebo (saline)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older.
• Diagnosed with primary RLS based on presence of a characteristic clinical history and the International restless legs syndrome study group (IRLSSG) diagnostic criteria.
• A minimum score of 11 on the RLS rating scale (this is equivalent to a minimum rating of moderate severity).
• If subjects are on medications for RLS, the medication regimen must be stabilized for greater than 6 weeks prior to entering the study.

You may not qualify if:

• Subjects with any abnormal findings on neurological exam.
• Subjects with a dermatologic disorder that precludes injections in the legs.
• Subjects with a positive urine pregnancy test.
• Subjects without the capacity to give informed consent.
• Subjects taking aminoglycosides, chloroquine, clindamycin, hydroxychloroquine, magnesium sulfate, quinidine, or an anticoagulant.
• Subjects with abnormal clinical chemistry, hematology or urine drug screen by laboratory testing.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Blasi J, Chapman ER, Link E, Binz T, Yamasaki S, De Camilli P, Sudhof TC, Niemann H, Jahn R. Botulinum neurotoxin A selectively cleaves the synaptic protein SNAP-25. Nature. 1993 Sep 9;365(6442):160-3. doi: 10.1038/365160a0.

  PMID: 8103915 BACKGROUND

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Botulinum Toxins, Type A; onabotulinum toxin A

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Fatta Nahab
• Organization: NINDS/NIH

nahabf@ninds.nih.gov

301-496-9526

Study Officials

• Fatta Nahab, MD

  NINDS/NIH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Investigator

Study Record Dates

• First Submitted: May 25, 2007
• First Posted: May 28, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 26, 2012
• Results First Posted: April 26, 2012

Record last verified: 2012-04

Locations

US (1)